MOVIPREP ORANGE powder for oral solution sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium sulfate, Quantity: 7.5 g; macrogol 3350, Quantity: 100 g; potassium chloride, Quantity: 1.015 g; ascorbic acid, Quantity: 4.7 g; sodium ascorbate, Quantity: 5.9 g; sodium chloride, Quantity: 2.691 g

Available from:

Norgine Pty Ltd

INN (International Name):

Ascorbic acid,macrogol 3350,potassium chloride,sodium ascorbate,sodium chloride,sodium sulfate

Pharmaceutical form:

Powder

Composition:

Excipient Ingredients: acesulfame potassium; aspartame; Flavour

Administration route:

Oral

Units in package:

4 sachets

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

For bowel cleansing prior to any clinical procedure requiring a clean bowel e.g. bowel endoscopy, lower gastrointestinal tract radiology or digestive tract surgery.

Product summary:

Visual Identification: Free flowing powder; Container Type: Sachet; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2013-02-27

Patient Information leaflet

Moviprep Orange Consumer Medicine Information – May 2023
- 1 -
MOVIPREP
®
ORANGE POWDER FOR ORAL SOLUTION
Macrogol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium
chloride and potassium chloride.
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Moviprep Orange powder for oral solution.
It does not contain all the available information. It does not
take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MOVIPREP ORANGE IS USED FOR
Moviprep Orange is a type of medicine called a bowel
preparation. It makes your bowels clean so that they are
ready for examination or surgery. Moviprep Orange works
by emptying the contents of your bowels, so you should
expect to have lots of watery bowel movements.
Moviprep Orange is an orange flavoured powder contained
in four sachets. There are two large sachets (Sachet A) and
two small sachets (Sachet B). You need all of these for one
treatment.
Moviprep Orange is intended for adults (18 years of age and
older), including the elderly, before any clinical procedure
that needs a clean bowel.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN RECOMMENDED FOR YOU.
BEFORE YOU TAKE MOVIPREP ORANGE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MOVIPREP ORANGE:

if
you
are
allergic
(hypersensitive)
to
the
active
ingredients or any of the other ingredients of Moviprep
Orange (listed in ‘Product Description’)

if you have a blockage in your intestine (gut)

if you have an opening in the wall of your stomach or
bowel (bowel perforation)

if
you
experience
problems
with
food
and
fluid
emptying from your stomach (gastric retention)

if you have paralysis of the gut (this often happens
after an operation to the abdomen)

if you suffer from phenylketonuria. This is a hereditary
inability of

Summary of Product characteristics

MOVIPREP Orange Product Information – 03 May 2023
Page 1
AUSTRALIAN PRODUCT INFORMATION - MOVIPREP
® ORANGE
(MACROGOL 3350, SODIUM CHLORIDE, SODIUM SULFATE,
POTASSIUM CHLORIDE, ASCORBIC ACID AND SODIUM
ASCORBATE) POWDER FOR ORAL SOLUTION
1 NAME OF THE MEDICINE
Macrogol 3350, sodium chloride, sodium sulfate, potassium chloride,
ascorbic acid and
sodium ascorbate.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SACHET A:
Macrogol 3350
100 g
Sodium sulfate
7.5 g
Sodium chloride
2.691 g
Potassium chloride
SACHET B:
1.015 g
Ascorbic acid
4.7 g
Sodium ascorbate
5.9 g
The concentration of electrolyte ions when both sachets are made up to
1 litre of
solution is:
Sodium
181.6 mmol/L (of which not more than 56.2 mmol is absorbable)
Sulfate
52.8 mmol/L
Chloride
59.8 mmol/L
Potassium
14.2 mmol/L
Ascorbate
56.5 mmol/L
Contains aspartame and glucose. Phenylketonurics are warned that this
product contains
aspartame (phenylalanine). See Section 4.3 ‘CONTRAINDICATIONS.
The complete treatment contains 8.4 g of sodium and 1.1 g of
potassium. See Section
4.4 Special Warnings and Precautions for Use.
For full list of excipients, see Section 6.1 List of Excipients.
3 PHARMACEUTICAL FORM
Powder for Oral Solution
4 CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
_ _
For bowel cleansing prior to any clinical procedure requiring a clean
bowel, e.g., bowel
endoscopy, lower gastrointestinal tract radiology or digestive tract
surgery.
MOVIPREP Orange Product Information – 03 May 2023
Page 2
_4.2 DOSE AND METHOD OF ADMINISTRATION _
_ _
A course of treatment consists of two litres of MOVIPREP Orange.
It is strongly recommended that patients also drink a further one
litre of clear liquid to
prevent them from feeling thirsty and becoming dehydrated. “Clear
liquids” include:

water,

clear soup,

tea or coffee without milk or non-dairy creamer,

all of the following liquids which are not coloured red or purple:
fruit juices without
pulp, carbonated and non-carbonated soft drinks, fruit flavoured
cordials.
Note: patients shou